Article

IVDR amendment proposal update: moving on up to adoption

01 Dec 2021, I recently reported about the proposal to amend the IVDR immediately when it came out – please excuse the initial inaccuracies in the post on the subject of amendments to article 5…

Article

Proposal to manage IVDR

15 Oct 2021, It had been been in the works for some time, although it also seemed unlikely for quite some time that this would happen. The implementation of the IVDR had been the slow…

Article

Happy MDR DoA and Swixit / noTurkxit day!

26 May 2021, As they say: this is the first day of the rest of your life, and in a way it is. The MDD is dead, long live the MDR! The (AI)MDD is no…

Article

The Enriched MDR and IVDR – finally available

24 May 2021, Finally and just in time for the date of application of the MDR: here it is, the book that I’ve been working on for a long long time. It turns out that…

Article

The Enriched MDR and IVDR – finally available

24 May 2021, Erik Vollebregt

Finally and just in time for the date of application of the MDR: here it is, the book that I’ve been working on for a long long time. It turns out that writing books while having a more than full-time job running a law firm and being a busy lawyer is a bit of a […]

Article

The new EU AI regulation proposal, medical devices and IVDs

05 May 2021, Now this is fun: at a time just before the date of application of the MDR when we do not even have harmonised standards for the new software requirements in Annex I,…

Article

MDR date of application next month – and the book

12 Apr 2021, Finally! Another post on this blog. You would think that I would write a lot on a blog like this just before the date of application of the MDR next month, right?…

Article

Finally remote initial audits, or not (yet)?

24 Jan 2021, When the Commission recently published the Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed…

Article

Outlook for 2021 – and happy new year!

29 Dec 2020, Something new for the end of the year: a new year’s vlog with my rough 2021 outlook. This outlook is far from complete and not comprehensive at all, and it leaves out…